MAUDE Adverse Event Report: CORDIS CORPORATION SABER 4MM10CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48004010S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.This device is available for analysis but has not yet been received.
Event or Problem Description
As reported, the balloon of the saber 4mm 10cm could not be raised to nominal pressure (8atm).The balloon was removed from the patient, the balloon was expanded outside the body, and it was noticed that the balloon had leakage from a pinhole.The treatment was successful after it was replaced with a new non-cordis balloon catheter of the same size.There was no reported injury to the patient.The procedure was to treat stenotic lesions in the left superficial femoral artery, popliteal artery, and pulmonary artery.A 5f non-cordis sheath was inserted through the left common femoral artery with an ipsilateral antegrade puncture.The sheath crossed the lesion along with the device.They both passed through the lesion and was prepared to use for pop lesion dilation.Pressure was applied with the inflation device.The device will be returned for evaluation.
Event or Problem Description
As reported, the balloon of the saber 4mm 10cm could not be raised to nominal pressure (8atm).The balloon was removed from the patient, the balloon was expanded outside the body, and it was noticed that the balloon had leakage from a pinhole.The treatment was successful after it was replaced with a new non-cordis balloon catheter of the same size.There was no reported injury to the patient.The procedure was to treat stenotic lesions in the left superficial femoral artery, popliteal artery, and pulmonary artery.A 5f non-cordis sheath was inserted through the left common femoral artery with an ipsilateral antegrade puncture.The sheath crossed the lesion along with the device.They both passed through the lesion and was prepared to use for pop lesion dilation.Pressure was applied with the inflation device.The device will be returned for evaluation.Additional information was requested; however, the information was not obtained after multiple attempts.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, g3, h1, h2, h3 and h6.As reported, the balloon of the saber 4mm 10cm could not be raised to nominal pressure (eight atm).The balloon was removed from the patient, the balloon was expanded outside the body, and it was noticed that the balloon had leakage from a pinhole.The treatment was successful after it was replaced with a new non-cordis balloon catheter of the same size.There was no reported injury to the patient.The procedure was to treat stenotic lesions in the left superficial femoral artery, popliteal artery, and pulmonary artery.A 5f non-cordis sheath was inserted through the left common femoral artery with an ipsilateral antegrade puncture.The sheath crossed the lesion along with the device.They both passed through the lesion and was prepared to use for pop lesion dilation.Pressure was applied with the inflation device.Additional information was requested; however, the information was not obtained after multiple attempts.The device was returned for analysis.A non-sterile saber 4mm x 10cm 90 percutaneous transluminal angioplasty (pta) unit was received for analysis inside a plastic bag.Per visual analysis, no anomalies could be observed on the unit by the naked eye.Per functional testing, a lab sample inflator/deflator device partially filled with water was attached to the inflation lumen of the unit and pressure was applied.However, a leakage was observed at a rupture in the proximal area of the balloon.No other anomalies were observed.Per microscopic analysis, sem was performed to identify the possible root cause of the balloon rupture.Results showed that the saber 4mm x 10cm 90 catheter complaint unit presented evidence of a ruptured condition explained in the complaint along with scratch marks located on the external surface of the balloon, this type of damage is commonly caused during the interaction of the material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the surface probably led to the damaged condition found on the received device.It seems the material near the damage was ruptured with a sharp object from the outside of the device resulting in the rupture of the balloon.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82227907 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage - during positive pressure¿ was confirmed during functional analysis.However, the exact cause could not be determined.Sem analysis revealed scratch marks on the outer portion of the balloon and a leakage was noted coming from the proximal area of the balloon.It appears the balloon was damaged by the interaction of the balloon material with a sharp object like calcified spicules located on the lesion or a mechanical damage.The vessel was described as stenotic; therefore, based on the analysis provided it is likely these vessel characteristics contributed to the events reported.According to the warnings in the safety information in the instructions for use ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion.The balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over-pressurization.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82227907 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the balloon of the saber 4mm 10cm could not be raised to nominal pressure (8atm).The balloon was removed from the patient, the balloon was expanded outside the body, and it was noticed that the balloon had leakage from a pinhole.The treatment was successful after it was replaced with a new non-cordis balloon catheter of the same size.There was no reported injury to the patient.The procedure was to treat stenotic lesions in the left superficial femoral artery, popliteal artery, and pulmonary artery.A 5f non-cordis sheath was inserted through the left common femoral artery with an ipsilateral antegrade puncture.The sheath crossed the lesion along with the device.They both passed through the lesion and was prepared to use for pop lesion dilation.Pressure was applied with the inflation device.The device will be returned for evaluation.Additional information was requested; however, the information was not obtained after multiple attempts.

• Brand Name: SABER 4MM10CM 90
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15354273
• Report Number: 9616099-2022-05944
• Device Sequence Number: 1622640
• Product Code: LIT
• UDI-Device Identifier: 20705032069783
• UDI-Public: (01)20705032069783(17)240731(10)82227907
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: 48004010S
• Device Catalogue Number: 48004010S
• Device Lot Number: 82227907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 09/12/2022; 10/13/2022
• Initial Report FDA Received Date: 09/05/2022
• Supplement Report FDA Received Date: 10/07/2022; 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5 FR TERUMO; INDEFLATOR (IN4130: MERIT MEDICAL); NON-CORDIS BALLOON CATHETER
• Patient Sex: Unknown